Impact of Currently Recommended Postnatal Nutrition on Neonatal Body Composition

Preterm Birth Clinical Trial

Official title:

Impact of Currently Recommended Postnatal Nutrition on Neonatal Body Composition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622373
• Other study ID #: STUDY00002323
• Status: Completed
• Phase: N/A
• First received: November 16, 2015
• Last updated: July 18, 2016
• Start date: June 2015
• Est. completion date: January 2016

Study information

• Verified date: July 2016
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to gain information that may be useful in helping to figure out better or newer ways to provide nutrition to babies born premature.

Description:

Babies born premature weigh significantly less at the time of hospital discharge when compared to babies born at the corresponding age. The researchers in this study believe that the lower body weight at discharge may be due to lower muscle mass. However, there is no such information available for that at this time. It is important to have this information as babies who weigh less than normal at hospital discharge may develop higher blood pressure and higher sugar levels when they are 10-15 years old.

By doing this study, researchers will be able to have information about the baby's muscle mass, which will help the researchers to provide better nutrition to babies who are born premature. Researchers will also be able to determine if there are any differences in the muscle/fat mass based on the type of feeding (breast milk alone, formula alone or a combination of breast milk and formula). This information may be beneficial in helping to promote the appropriate type of feeding for babies born premature.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 23 Weeks to 42 Weeks

Eligibility

Inclusion Criteria:

• Newborns <32 weeks gestational age, singleton or multiple gestation

• 34-36 weeks gestational age newborns

• Term healthy infants from uncomplicated pregnancy

Exclusion Criteria:

• Babies with life threatening illness unlikely to survive

• Congenital and chromosomal anomalies

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Device:
• PEA POD Infant Body Composition System
The non-invasive device used in this study to measure a baby's body composition is a called a Pea Pod. The Pea Pod is a quick, safe, non-invasive and reliable bedside procedure used to measure changes in infant body composition.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Vishal Pandey, M.D.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Simon L, Frondas-Chauty A, Senterre T, Flamant C, Darmaun D, Rozé JC. Determinants of body composition in preterm infants at the time of hospital discharge. Am J Clin Nutr. 2014 Jul;100(1):98-104. doi: 10.3945/ajcn.113.080945. Epub 2014 May 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Fat mass percentage between 36 and 40 weeks in preterm infants	Body composition as determined by the PEA POD air displacement plathesmography would determine the fat mass percentage and the serial measure of this parameter would determine the changes in the fat mass percentage indicating the quality of growth between 36 and 40 weeks post conceptional age. At 40 weeks corrected age, the fat mass percentage of the premature infants would be compared with ten healthy term infants born to healthy mothers with uncomplicated pregnancies.	Change in the Fat mass percentage between 36 weeks and 40 weeks corrected age	No
Secondary	Comparison of the Fat mass percent between preterm infants at 40 weeks and those born at Term gestation.	The Fat mass percentage in preterm infants at the 40 weeks corrected age would be compared with healthy full term infants born following an uncomplicated pregnancy.	40 weeks corrected age	No